To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303
gel in combination with acyclovir, relative to acyclovir alone, for the treatment of
recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and
neighboring areas, in patients with AIDS.
Minimum age: 18 Years.
Maximum age: N/A.
Patients must have:
- AIDS, according to the CDC criteria.
- Documented recurrent (at least 1 prior episode) perineal (genital, perianal and
neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in
the active phase.
- Duration of current episode of recurrent HSV lesions of 3 days or less.
- Ability to read and write, must be intellectually competent, and able to understand
the purposes and risks of the study.
Patients with the following symptoms and conditions are excluded:
- Active internal anal or rectal herpes.
- Inability to comply with protocol.
- Impaired renal function.
Patients with the following prior conditions are excluded:
- Prior episode of recurrent genital herpes infection with documented clinical failure
of acyclovir as a treatment regimen.
- Uncompensated hepatic, cardiac, or renal failure within 1 month of the study.
- History of hypersensitivity to acyclovir.
- Previous enrollment in this study.
1. Treatment with another medication (topical, oral, or intravenous) with known
anti-HSV activity within the past 5 days.
- Systemic immunomodulatory therapy within 30 days prior to study.
- Previous treatment with SP-303.
Unchanged antiretroviral therapy for the 2 weeks prior to study.
Hosp Regional de Ponce - Area Vieja, Ponce 00731, Puerto Rico
San Juan AIDS Program, Santurce 00908, Puerto Rico
Sorra Research Ctr Inc / Med Forum, Birmingham, Alabama 35203, United States
Arizona Clinical Research Ctr Inc, Tucson, Arizona 85712, United States
Hill Top Research Ltd, Scottsdale, Arizona 85251, United States
Olive View Med Ctr, Sylmar, California 91342, United States
ViRx Inc, Palm Springs, California 92262, United States
Dermatology SVC - VAMC, Long Beach, California 90822, United States
Conant Med Ctr, San Francisco, California 94117, United States
King - Drew Med Ctr / Dept of Dermatology, Los Angeles, California 90059, United States
ViRx Inc, San Francisco, California 94109, United States
Summit Med Ctr / Adult Immunology Clinic, Oakland, California 94609, United States
Novum Inc, Washington, District of Columbia 20037, United States
Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States
Gary Richmond MD, Fort Lauderdale, Florida 33316, United States
IDC Research Initiative, Altamonte Springs, Florida 32701, United States
Dr Robert Schwartz, Fort Myers, Florida 33901, United States
Treasure Coast Infectious Disease Consultants, Vero Beach, Florida 32960, United States
Veterans Affairs Med Ctr of North Chicago, Chicago, Illinois 60064, United States
Johns Hopkins Univ / Division of Infectious Disease, Baltimore, Maryland 21205, United States
Saint Agnes Healthcare / Dept of Surgery, Baltimore, Maryland 21229, United States
Massachusetts Gen Hosp - Warren 505, Boston, Massachusetts 02114, United States
Medicine / Infectious Diseases, Minneapolis, Minnesota 55455, United States
Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
AIDS Ctr / Saint Vincents Hosp and Med Ctr, New York, New York 10011, United States
New York Univ Med Ctr, New York, New York 10016, United States
Paddington Testing Co Inc, Philadelphia, Pennsylvania 19103, United States
N Texas Ctr for AIDS & Clin Rsch, Dallas, Texas 75219, United States
Division of Infectious Diseases / Univ of Texas - Houston, Houston, Texas 77030, United States
Austin Infectious Disease Consultants, Austin, Texas 78705, United States
Dr Robert Holman, Arlington, Virginia 22205, United States
Novum Inc, Seattle, Washington 98122, United States
Univ of Washington Virology Research Clinic, Seattle, Washington 98122, United States